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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 303

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CYBERONICS - HOUSTON LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/18/2018
Event Type  Injury  
Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.

 
Event Description

It was reported by a patient that his vocal cord was nicked during surgery, causing his voice to be "out" for almost 6 months. It was stated that his voice did not return until a surgical procedure was performed on his vocal cord by an ent (ear, nose, throat) surgeon. The surgical procedure was performed after two other attempted treatments, including a "dose of liquid in his nose". It was stated that at the post-op follow up appointment for vns surgery, the patient had spoken to the surgeon's nurse practitioner. He had reported to her that he was more hoarse than when he had last replaced his lead and she stated that his hoarseness would last a week. He was diagnosed with laryngitis, and the patient stated that the loudest he could speak was a whisper. Operation notes from the patient's ent office regarding the patient's vocal cord paresis surgery. Left vocal cord paresis was diagnosed and the surgeon performed a microlaryngoscopy with left intracordal prolaryn injection. It was noted that the patient tolerated the procedure well and recoverd in good condition. No additional relevant information was received to date.

 
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Brand NameLEAD MODEL 303
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8127580
Report Number1644487-2018-02200
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number303-20
Device LOT Number204047
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/09/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/03/2018 Patient Sequence Number: 1
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